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Clinical Trials/NCT05078229
NCT05078229
Active, not recruiting
Not Applicable

Efficacy of a Mindfulness-Based Stress Management Program for Allogeneic HCT Caregivers

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country505 target enrollmentSeptember 16, 2021
ConditionsBurdenStress

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Burden
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Enrollment
505
Locations
1
Primary Endpoint
Patient Distress at 6 Month Follow-up (CESD)
Status
Active, not recruiting
Last Updated
3 months ago

Overview

Brief Summary

The purpose of the study is to understand whether different stress management interventions impact stress among HCT cancer caregivers and patients.

Registry
clinicaltrials.gov
Start Date
September 16, 2021
End Date
March 31, 2026
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Caregiver Inclusion Criteria:
  • Caring for a patient planning to receive an allogeneic HCT at Moffitt
  • Intending to remain primary caregiver throughout patient treatment (i.e., will be the caregiver the majority of the time)
  • Able to provide informed consent
  • Able to read and write in English
  • Owns a smartphone and is willing to download the study app
  • Patient Inclusion Criteria:
  • Receiving an allogeneic HCT at the cancer center
  • Able to provide informed consent
  • Able to read and write in English

Exclusion Criteria

  • Under 21 years of age
  • Unable to provide informed consent
  • Unable to read and write in English
  • Caregiver is unable to remain primary caregiver throughout patient treatment
  • Patient does not receive transplant at Moffitt Cancer Center

Outcomes

Primary Outcomes

Patient Distress at 6 Month Follow-up (CESD)

Time Frame: 6 Month Follow-up after end of treatment

Patient distress will be measured using the Center for Epidemiological Studies Depression Scale (CESD). The CESD is comprised of 20 4-point Likert scale items and has been commonly used among cancer caregivers. Participants rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

Patient Distress at 6 Month Follow-up (GAD-7)

Time Frame: 6 Month Follow-up after end of treatment

Patient distress will be measured using the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is comprised of 8 items on a 4-point Likert scale and has been used extensively among cancer caregivers. Participants rate the severity of his or her symptoms over the past two weeks. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions

Caregiver Burden at 2 Month Follow-up

Time Frame: 2 month follow up after end of treatment

Caregiver burden will be measured using the Zarit Burden Interview Short Form (ZBI). The ZBI is 12 items using a 5-point Likert scale assessing caregiver burden. Participants rate burden on a scale of 0 to 4, 0 indicating "rarely" an issue and 4 indicating "nearly always". The ZBI has been validated in populations of cancer caregivers and has demonstrated very good internal consistency and discriminative ability

Patient Distress at 2 Month Follow-up (CESD)

Time Frame: 2 Month Follow-up after end of treatment

Patient distress will be measured using the Center for Epidemiological Studies Depression Scale (CESD). The CESD is comprised of 20 4-point Likert scale items and has been commonly used among cancer caregivers. Participants rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

Caregiver Burden at End of Treatment

Time Frame: Up to 8 Weeks

Caregiver burden will be measured using the Zarit Burden Interview Short Form (ZBI). The ZBI is 12 items using a 5-point Likert scale assessing caregiver burden. Participants rate burden on a scale of 0 to 4, 0 indicating "rarely" an issue and 4 indicating "nearly always" The ZBI has been validated in populations of cancer caregivers and has demonstrated very good internal consistency and discriminative ability

Caregiver Burden at 6 Month Follow-up

Time Frame: 6 month follow up after end of treatment

Caregiver burden will be measured using the Zarit Burden Interview Short Form (ZBI). The ZBI is 12 items using a 5-point Likert scale assessing caregiver burden. Participants rate burden on a scale of 0 to 4, 0 indicating "rarely" an issue and 4 indicating "nearly always". The ZBI has been validated in populations of cancer caregivers and has demonstrated very good internal consistency and discriminative ability

Patient Distress at End of Treatment (CESD)

Time Frame: Up to 8 Weeks

Patient distress will be measured using the Center for Epidemiological Studies Depression Scale (CESD). The CESD is comprised of 20 4-point Likert scale items and has been commonly used among cancer caregivers. Participants rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

Patient Distress at End of Treatment (GAD-7)

Time Frame: Up to 8 Weeks

Patient distress will be measured using the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is comprised of 8 items on a 4-point Likert scale and has been used extensively among cancer caregivers. Participants rate the severity of his or her symptoms over the past two weeks. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions

Patient Distress at 2 Month Follow-up (GAD-7)

Time Frame: 2 Month Follow-up after end of treatment

Patient distress will be measured using the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is comprised of 8 items on a 4-point Likert scale and has been used extensively among cancer caregivers. Participants rate the severity of his or her symptoms over the past two weeks. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions

Secondary Outcomes

  • Patient Healthcare Utilization - unexpected clinic visits post discharge at 6 Month Follow-up(6 Month Follow-up after end of treatment)
  • Patient Healthcare Utilization - Readmissions to the hospital at 6 Month Follow-up(6 Month Follow-up after end of treatment)

Study Sites (1)

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